Randomized Evaluation of the effectiveness in terms of reduction of cerebral ischemia in patients undergoing carotid angioplasty load of different doses of clopidogrel (300vs600mg) and high-dose atorvastatin

Prospective randomized study to evaluate the efficacy of different protocols IN DRUG PREVENTION OF BRAIN DAMAGE AFTER Carotid angioplasty with stent implantation (CAROTID ARMYDA trial). - ARMYDA_CAROTID

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005330-18-IT

Enrollment

150

Registered

2011-12-20

Start date

2011-11-08

Completion date

Unknown

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with carotid stenosis undergoing angioplasty with stent implantation MedDRA version: 14.1 Level: SOC Classification code 10047065 Term: Vascular disorders System Organ Class: 10047065 - Vascular disorders

Interventions

Trade Name: PLAVIX*30CPR RIV 300MG Pharmaceutical Form: Tablet INN or Proposed INN: CLOPIDOGREL MONOSULFATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Tra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: symptomatic or asymptomatic patients with reflected economic colordoppler angioTAC and carotid vascular disease of significant (> 70% diameter reduction according to the NASCET criteria or characteristics velocimetric) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: - Patients with recent ischemic stroke and / or presence of acute injury / subacute MRI of the brain. - Patients with active bleeding or with contraindications taking dual antiplatelet therapy - Patients with contraindications to statin therapy for history of severe liver disease, muscle diseases, or otherwise elevated baseline transaminase or CK - Patients with contraindications to MR examination (pacemaker / claustrophobic).

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the effectiveness of various pharmacologic regimens with - Effect on the 24 hours of new cerebral ischemic events ipsilateral to carotid artery treated, as manifested in the post-nuclear magnetic resonance detectable PTA or after the procedure by increasing serum levels of NSE or SB100;Secondary Objective: -30;Primary end point(s): - Effect on the 24 hours of new cerebral ischemic events ipsilateral to carotid artery treated, as manifested in the post-nuclear magnetic resonance detectable PTA or after the procedure by increasing serum levels of NSE or SB100;Timepoint(s) of evaluation of this end point: 24 HOURS	—

Measure

Time frame

Main Objective: Evaluate the effectiveness of various pharmacologic regimens with - Effect on the 24 hours of new cerebral ischemic events ipsilateral to carotid artery treated, as manifested in the post-nuclear magnetic resonance detectable PTA or after the procedure by increasing serum levels of NSE or SB100;Secondary Objective: -30;Primary end point(s): - Effect on the 24 hours of new cerebral ischemic events ipsilateral to carotid artery treated, as manifested in the post-nuclear magnetic resonance detectable PTA or after the procedure by increasing serum levels of NSE or SB100;Timepoint(s) of evaluation of this end point: 24 HOURS

—

Secondary

Measure	Time frame
Secondary end point(s): - 30-day incidence of stroke (defined as a neurological deficit lasting> 24 hours with evidence of ischemic lesion on MRI brain) or TIA. - Incidence of major and minor bleeding (TIMI) 20, and vascular access site complications (hematoma, pseudoaneurysm, AV fistula).;Timepoint(s) of evaluation of this end point: 30 DAYS	—

Countries

Italy

Contacts

Public ContactCARDIOLOGIA

POLICLINICO UNIVERSITARIO CAMPUS BIO-MEDICO DI ROMA

g.patti@unicampus.it06225411612

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026